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RIOMET Drug Profile
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» See Plans and PricingWhich patents cover Riomet, and what generic alternatives are available?
Riomet is a drug marketed by Ranbaxy and Sun Pharm and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has eighteen patent family members in eighteen countries.
The generic ingredient in RIOMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Riomet
A generic version of RIOMET was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.
Summary for RIOMET
| International Patents: | 18 |
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 131 |
| Clinical Trials: | 32 |
| Patent Applications: | 38 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RIOMET |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RIOMET |
| DailyMed Link: | RIOMET at DailyMed |
Recent Clinical Trials for RIOMET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | Phase 2 |
| Tianjin Medical University Cancer Institute and Hospital | Phase 2 |
| National Cancer Institute (NCI) | Phase 1 |
Pharmacology for RIOMET
| Drug Class | Biguanide |
Paragraph IV (Patent) Challenges for RIOMET
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RIOMET | SOLUTION;ORAL | metformin hydrochloride | 021591 | 2018-02-02 |
US Patents and Regulatory Information for RIOMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ranbaxy | RIOMET | metformin hydrochloride | SOLUTION;ORAL | 021591-001 | Sep 11, 2003 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Sun Pharm | RIOMET ER | metformin hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 212595-001 | Aug 29, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for RIOMET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 0113102 | Start Trial |
| Japan | 2004505913 | Start Trial |
| Yugoslavia | 8803 | Start Trial |
| Iceland | 6709 | Start Trial |
| Israel | 154307 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RIOMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261586 | 15/2012 | Austria | Start Trial | PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124 |
| 1412357 | CA 2008 00035 | Denmark | Start Trial | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
| 1532149 | 92128 | Luxembourg | Start Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE |
| 2498758 | LUC00152 | Luxembourg | Start Trial | PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
| 1506211 | 132014902277722 | Italy | Start Trial | PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
